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Comments on Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances

Comments of the Patient, Consumer, and Public Health Coalition
on
Reclassification of Sorbent Hemoperfusion Devices for the Treatment of Poisoning and Drug Overdose; Effective Date of Requirement for Premarket Approval for Sorbent Hemoperfusion Devices To Treat Hepatic Coma and Metabolic Disturbances
[Docket No. FDA-2012-M-0076]

Many member organizations of the Patient, Consumer, and Public Health Coalition do not usually comment on regulatory decisions regarding specific devices or types of devices. However, we are writing to comment on the above because of our concerns about clearing a group of devices through the 510(K) process for one use and through a more rigorous process for a different use. In addition, the Food and Drug Administration’s (FDA’s) proposal for these devices raises fundamental questions about whether the Center for Devices and Radiological Health is following the law regarding the regulation of devices that are life-sustaining or life-supporting.

We are writing to express our strong opposition to the following proposed regulatory actions, which would threaten patient safety:

Down-classifying sorbent hemoperfusion devices — which are life-sustaining or life-supporting devices for all current indications —from Class III (high-risk devices) to Class II (moderate-risk devices) and allowing them to be reviewed through the 510(k) process for one type of treatment while maintaining them as Class III devices for a different treatment. These are high-risk devices that can cause serious injury and death, and therefore they should remain in Class III and be reviewed through the premarket approval (PMA) process for all indications; and

Suggesting that it might be appropriate for a manufacturer that plans to market a sorbent hemoperfusion device for treatment of hepatic coma and metabolic disturbances to submit a notice of completion of a product development protocol (PDP) — which does not require premarket clinical trials — instead of a PMA application.

Sorbent hemoperfusion devices consist of an extracorporeal blood system and a container filled with adsorbent material that removes a wide range of toxic and normal substances from blood flowing through it. Because they are life-sustaining and life-supporting, the Gastroenterology-Urology Device Classification Panel recommended in 1981 that sorbent hemoperfusion systems be classified into class III and in 1983 FDA placed these devices into class III. Although there are additional data on these devices since they were first introduced, the list of known “Risks to Health” includes 16 separate entries, several of which are too serious to justify these devices being down-classified to class II.[1] The list of health risks includes hypotension, blood clotting, electrical shock, leaking of the adsorbent agent into the lungs, leaching of toxic substance from the device, removal of vital nutrients and hormones from patients, and lack of effectiveness in removing toxic substances from the blood.

We strongly disagree with the FDA’s assessment that sorbent hemoperfusion systems intended for the treatment of poisoning and drug overdose should be reclassified into class II, because “there is now adequate effectiveness information sufficient to establish special controls” to provide assurance of safety and effectiveness. In fact, the FDA does not cite specific references to that information, raising questions about whether the information is based on scientific research or more subjective information. Moreover, since each new device is uniquely different from those already on the market, premarket clinical trial data are needed to ensure that each new hemoperfusion system will be safe and effective, even if those already on the market appear to be.

“Labeling controls” is listed as one of the proposed special controls for the device when it will be used for treatment of poisoning and drug overdose. However, regardless of labeling, physicians are likely to use the device off-label for treating hepatic coma and metabolic disturbances, at a time when the FDA is requiring a separate review for those uses.

For the treatment of hepatic coma and metabolic disturbances, the FDA has concluded that “the safety and effectiveness of these devices have not been established by adequate scientific evidence” and the device for these purposes needs a PMA or PDP. We agree with the PMA requirement, but not with the less stringent PDP alternative. A PDP must provide: (1) A description of the device, (2) preclinical trial information (if any), (3) clinical trial information (if any), (4) a description of the manufacturing and processing of the devices, (5) the labeling of the device, and (6) all other relevant information about the device. In other words, proof of safety and efficacy from clinical trial data is not required, as it would be for a PMA.

To ensure public health and patient safety, sorbent hemoperfusion devices for the treatment of poisoning, drug overdose, hepatic coma, and metabolic disturbances should remain class III devices and go through the more stringent PMA process, which requires clinical trials and inspections.

As members of the Patient, Consumer, and Public Health Coalition, we are very concerned about the lack of stringent criteria requiring a Class III designation and PMA review for medical devices that have never been proven safe or effective in clinical trials and whose intended use life-sustaining or life-supporting, and which can kill or seriously harm a patient. We respectfully remind the FDA of the 2011 Institute of Medicine report urging the FDA to require evidence of safety and effectiveness for medical devices, a recommendation that is all the more important for high-risk devices such as sorbent hemoperfusion devices.